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Clinical Trials/NCT01881516
NCT01881516UnknownPhase 2

Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue（CRF）

Fudan University0 sites32 target enrollmentStarted: July 1, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Enrollment
32
Primary Endpoint
Brief Fatigue Inventory, BFI
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

we plan to conduct this trial to find out：

  • If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or radio-therapy？
  • How about the extent it relieves？the safety and applicability ？
  • What's the possible influential factor and mechanism ？

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who are pathologically/cytologically diagnosed as NSCLC and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment;
  • •Participants who meet the diagnosis criteria of CRF（ICD-10 criteria);
  • •The first time to receive acupuncture treatment;
  • •The age is between 18 and 65 years old;
  • •Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above;
  • •ECOG performance status 0, 1 or
  • •Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
  • •Have not taken any hypnotic, melatonin, or antidepressants within 30 days;
  • •Willing to finish the whole observation period;
  • •With written consent form signed by themselves.

Exclusion Criteria

  • •Participants in other clinical research;
  • •Can not be pathologically or cytologically diagnosed as NSCLC;
  • •ECOG 3~4;
  • •Pregnant woman;
  • •>65 or <18 years old;
  • •Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue;
  • •Patients who have received acupuncture ever before;
  • •Received surgery, immunotherapy or target therapy within one month before the recruition；
  • •Taking warfarin or heparin, a bleeding tendency exists;
  • •Infection, ulceration or hyperalgesia at or near the local acupoints' skin，or with active infections；
  • •There are cerebral vascular accident history or spinal cord injury history；
  • •Combination with other serious diseases or condition, including congestive heart failure, Unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.;
  • •Patients with a life expectancy < 3 months;
  • •Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.

Arms & Interventions

Acupuncture

Active Comparator

Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks

Intervention: acupuncture (Device)

sham acupuncture

Sham Comparator

Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.

Intervention: sham acupuncture (Device)

Outcomes

Primary Outcomes

Brief Fatigue Inventory, BFI

Time Frame: 12 months

Secondary Outcomes

  • MDASI-C(12 months)
  • number of adverse events of acupuncture(24 months)
  • FACT-L(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

xie jing

attending

Fudan University

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